News and Articles
Melatonin: The Benefits vs. the Risks of the Dietary Supplement
Melatonin was first identified by Aaron B. Lerner, an American physician and dermatologist at Yale University, in 1958. Dr. Lerner and his colleagues were initially investigating a cure for vitiligo, an autoimmune disorder characterized by the loss of skin pigmentation. Although the experimentation failed to find a cure for skin disorders, subsequent research revealed that…
The Risks of Employees Driving in Foreign Territories
The hazards of driving increase when you or your employees drive in unfamiliar territory. This is especially true when driving in foreign territories without knowing the driving rules and habits within the country. Being unfamiliar with local regulations, failing to adhere to them, or making incorrect assumptions increases the likelihood of accidents. Factors That Increase…
Organ Chip Technology
Life science companies seeking FDA approval must not only establish a new medicine’s efficacy but also comply with rigorous safety protocols and procedures. The process is time-consuming and costly: the financial burden associated with developing and securing market approval for a new compound is estimated at $2.5 billion and can take over a decade, with…
Gene Therapy: Challenges and Regulatory Developments
Our last gene therapy article highlighted several novel cures for rare, life-threatening illnesses using gene therapy technology. Many more treatments based on gene therapy are in the clinical trial phase. Despite the remarkable results thus far, significant challenges lie ahead. As with any new treatment modality, scientists must be cautious in their approach, carefully studying…
Staying Ahead in Life Sciences: 2023 in Review and 2024 Trends – Part 3
As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar with Kim Schmid, Executive Managing Partner at Bowman & Brooke. BLS is offering a series of three articles highlighting information from the webinar, such…
Staying Ahead in Life Sciences: 2023 in Review and 2024 Trends – Part 2
As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar with Kim Schmid, Executive Managing Partner at Bowman & Brooke. BLS is offering a series of three articles highlighting information from the webinar, such…
Staying Ahead in Life Sciences Litigation: 2023 in Review and 2024 Trends – Part 1
As part of the life science community, Berkley Life Sciences (BLS) stays current on litigation trends and regulatory developments that affect the industry. BLS presents these updates in an annual webinar in partnership with Kim Schmid, Executive Managing Partner at Bowman & Brooke. BLS is offering a series of three articles highlighting information from the…
Medical Devices Powered by Lithium-ion Batteries: Safety Considerations
The development of lithium-ion batteries, also known as “Li-ion” batteries, has brought game-changing portable, rechargeable power to a vast array of products, including modern-day smartphones and electric cars. The life science industry has taken notice: many medical devices, ranging from electric wheelchairs to defibrillators to oxygen concentrators, have been designed to work with lithium-ion batteries….
“Nuclear” Verdicts Go “Thermonuclear”: What is the Impact on Life Science Companies?
Researchers studying litigation in the United States over the past several decades have coined the phrase “nuclear” verdict to mean a jury award exceeding $10 million. There is no question that over the past twenty-plus years, the number of nuclear verdicts, and the amounts awarded, have increased exponentially, to the extent that one self-described independent…
Tianeptine, known as “Gas Station Heroin,” Joins the Ranks of Illegal Drugs Harming Americans
As recently as January 23, 2024, the U.S. Food and Drug Administration (“FDA”) reiterated a previous public health advisory to consumers: do not purchase or use any product containing the illegal and potentially dangerous substance tianeptine. Products containing tianeptine are known colloquially as “gas station heroin” because they: (1) are readily available in gas stations,…
